MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-48K DISP PUNCH 4.8MM; INSTRUMENTS, SURGICAL, CARDIOV

Catalog Number DP-48K

Device Problems Failure to Cut (2587); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual inspection was performed to 1 piece from product code dp-48k (pu dp-48k disp punch 4.8mm) received as part of this complaint, piece is received without damage; this sample was not received in its original packaging.Dimensional testing according to was performed to the metal components once disassembled obtaining acceptable dimensional results.As per quality form qa-pun-003/f1, the unit was activated by triggering the device in order to detect any obstructions and to show a smooth return of the metal core, sample available did not show any problem during this testing.The device history record of batch number provided has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No corrective actions can be established since the visual, dimensional and functional testing demonstrated that product was manufactured according to the specifications.The customer complaint is not confirmed since the sample received has been found within the dimensional and functional requirements.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the punch was not cutting the aorta completely.They backed the item out and tried to use it again and on the 2nd attempt it would not open; guess tissue was stuck in it.They were able to use scissors to complete the procedure.There was no patient harm and the patient is doing fine.

• Brand Name: PU DP-48K DISP PUNCH 4.8MM
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOV
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 7282677
• MDR Text Key: 100558164
• Report Number: 3004365956-2018-00045
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2022
• Device Catalogue Number: DP-48K
• Device Lot Number: 74F1702736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2018
• Initial Date FDA Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1